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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K010630
Device Name Y-TZP POWDER AND PROCERA ALLZIRKON
Applicant
PROCERA SANDVIK, INC.
1872 MCBRIDE AVE.
FAIR LAWN,  NJ  07410 -2812
Applicant Contact MARTIN STERNER
Correspondent
PROCERA SANDVIK, INC.
1872 MCBRIDE AVE.
FAIR LAWN,  NJ  07410 -2812
Correspondent Contact MARTIN STERNER
Regulation Number872.6660
Classification Product Code
EIH  
Date Received03/02/2001
Decision Date 04/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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